Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Calcutta National Medical College and Hospital
• Treatments: Letrozole; Mifepristone; Misoprostol

Criteria

INCLUSION CRITERIA :

• Women older than 18years who will give consent regarding medical management of missed abortion

• First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography

• Hemoglobin level more than 12mg/dl

EXCLUSION CRITERIA :

• Hemodynamically unstable patient

• Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen

• History or clinical evidence of any thromboembolic impairment or deep venous thrombosis

• Having intra-uterine device

• Present or previous use of corticosteroids

• History of any malignancy

• Existing cardiovascular disease contraindicating misoprostol